Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?

Su Hyun Lee; Jin Tae Jung; Dong Wook Lee; Chang Yoon Ha; Kyung Sik Park; Si Hyung Lee; Chang Heon Yang; Youn Sun Park; Seong Woo Jeon

doi:10.4166/kjg.2015.66.2.85

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Lee, Jung, Lee, Ha, Park, Lee, Yang, Park, and Jeon: Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?

Original Article

Korean J Gastroenterol 2015;66(2):85-91.

Published online: 4 October 2015

DOI: https://doi.org/10.4166/kjg.2015.66.2.85

Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?

Su Hyun Lee, Jin Tae Jung¹, Dong Wook Lee¹, Chang Yoon Ha², Kyung Sik Park³, Si Hyung Lee⁴, Chang Heon Yang⁵, Youn Sun Park⁶, Seong Woo Jeon

Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea

¹Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea

²Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea

³Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea

⁴Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea

⁵Department of Internal Medicine, Dongguk University School of Medicine, Gyeongju, Korea

⁶Department of Internal Medicine, Soonchunhyang University College of Medicine, Gumi, Korea

Correspondence to: Seong Woo Jeon, Gastric Cancer Center, Kyungpook National University Medical Center, 807 Hoguk-ro, Buk-gu, Daegu 41404, Korea. Tel: +82-53-200-2602, Fax: +82-53-200-2027, E-mail: sw-jeon@hanmail.net

Received 23 March 2015 Revised 16 June 2015 Accepted 13 July 2015

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims

Endoscopic hemoclip application is an effective and safe method of endoscopic hemostasis. We conducted a multicenter retrospective study on hemoclip and hemoclip combination therapy based on prospective cohort database in terms of hemostatic efficacy not in clinical trial but in real clinical practice.

Methods

Data on endoscopic hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB) were prospectively collected from February 2011 to December 2013. Among 1,584 patients with NVUGIB, 186 patients treated with hemoclip were enrolled in this study. Subjects were divided into three groups: Group 1 (n=62), hemoclipping only; group 2 (n=88), hemoclipping plus epinephrine injection; and group 3 (n=36), hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. Primary outcomes included rebleeding, other therapeutic management, hospitalization period, fasting period and mortality. Secondary outcomes were bleeding associated mortality and overall mortality.

Results

Active bleeding and peptic ulcer bleeding were more common in group 3 than in group 1 and in group 2 (p<0.001). However, primary outcomes (rebleeding, other management, morbidity, hospitalization period, fasting period and mortality) and secondary outcomes (bleeding associated mortality and total mortality) were not different among groups.

Conclusions

Combination therapy of epinephrine injection and other modalities with hemoclips did not show advantage over hemoclipping alone in this prospective cohort study. However, there is a tendency to perform combination therapy in active bleeding which resulted in equivalent hemostatic success rate, and this reflects the role of combination therapy in clinical practice.

Keywords: Gastrointestinal hemorrhage, Endoscopic hemostasis

References

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Fig. 1.

Overall schema of patient enrollment. Group 1, treated by hemoclipping only; group 2, treated by hemoclipping plus epinephrine injection; group 3, treated by hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. NVUGIB, non-variceal upper gastrointestinal bleeding; Plt, platelet.

Table 1.

Patient Baseline Characteristics

	Group 1 (n=62)	Group 2 (n=88)	Group 3 (n=36)	p-value
Age (yr)	61.21±16.039	63.23±16.335	60.58±17.480	0.639
Sex (male)	50 (80.6)	70 (79.5)	28 (77.8)	0.738
Hemoglobin (g/dL)	9.752±3.0410	9.108±2.7630	8.117±2.9418	0.028
Number of clip	2.98±1.694	2.83±1.503	3.14±2.416	0.660
EGD finding
Upper GI ulcer (GU+DU)	33 (53.2)	73 (83.3)	32 (88.9)	<0.001
Gastric ulcer	26 (41.9)	50 (56.8)	23 (63.9)	0.026
Duodenal ulcer	7 (11.3)	23 (26.1)	9 (25.0)	0.060
Mallory-Weiss tears	15 (24.2)	2 (2.3)	2 (5.6)	<0.001
Dieulafoy	12 (19.4)	11 (12.5)	0 (0)	0.006
Angiodysplasia	1 (1.6)	1 (1.1)	4 (2.2)	0.270
Gastric cancer	1 (1.6)	1 (1.1)	0 (0)	0.473
Hypovolemic shock^a	26 (41.9)	39 (44.3)	20 (55.6)	0.225
Active bleeding ^b	9 (14.5)	25 (28.4)	17 (47.2)	<0.001
Forrest IIa, IIb bleeding	31 (50.0)	49 (55.7)	14 (38.9)	0.538
Forrest IIc, III bleeding	0 (0)	1 (1.1)	0 (0)	0.844
Endoscopic hemostatic success	62 (100)	85 (96.6)	35 (97.2)	0.270

Values are presented as mean±SD or n (%).

Group 1, treated by hemoclipping only; group 2, treated by hemoclipping plus epinephrine injection; group 3, treated by hemocliping and epinephrine injection plus other endoscopic hemostatic modalities.

EGD, endogastroduodenoscopy; GI, gastrointestinal; GU, gastric ulcer; DU, duodenal ulcer.

^a Defined mean blood pressure below <90 mmHg or heart rate above >100 beat/min

^b which is Forrest Ia or Forrest Ib bleeding.

Table 2.

Outcomes according to the Group

	Group 1 (n=62)	Group 2 (n=88)	Group 3 (n=36)	p-value
Primary outcome
Rebleeding ^a	7 (11.3)	7 (8.0)	4 (11.1)	0.867
Other management ^b	2 (3.2)	2 (2.3)	5 (11.1)	0.115
Morbidity and mortality	3 (4.8)	8 (9.1)	1 (2.8)	0.893
Rockall score (RS)
Pre-RS ^c	2.29±1.653	2.33±1.700	2.42±1.645	0.937
Full-RS ^d	4.92±2.043	5.20±1.913	5.28±1.750	0.583
Non per oral time (hr)	93.19	88.71	94.83	0.600
Admission time (hr)	161.44	204.17	303.90	0.164
Secondary outcome
Bleeding associated mortality	0 (0)	3 (3.4)	0 (0)	0.733
Overall mortality	1 (1.6)	4 (4.5)	6 (3.2)	0.626

Values are presented as mean±SD or n (%).

^a Defined that recurrent bleeding is occur within 30 days after initial endoscopic hemostasis.

^b The case that performing angioembolization or operation due to failure of endoscopic hemostasis.

^c Calculated without endoscopic finding, for each case was based on points assigned for 3 clinical variables: patient age at presentation, shock status based on initial heart rate and systolic pressure, and presence of comorbid disease.

^d Calculated for each case based on points assigned for each of 3 aforementioned clinical variables plus 2 endoscopic variables: the endoscopic diagnosisand stigmata of recent hemorrhage based on the initial endoscopic examination.

Table 3.

Outcomes according to Endoscopic Hemostasis Success or Fail

	Endoscopic hemostasis success	Endoscopic hemostasis fail	p-value
Primary outcome
Rebleeding	17 (9.3)	1 (25.0)	0.337
Mortality	11 (6.0)	1 (25.0)	0.236
Secondary outcome
Bleeding associated mortality	2 (1.1)	1 (33.3)	0.063
Overall mortality	5 (2.7)	1 (25.0)	0.124

Values are presented as n (%).

Table 4.

Use of Proton Pump Inhibitor (PPI) according to the Group of High Risk

	Group 1 (n=57)	Group 2 (n=82)	Group 3 (n=35)	p-value
Use of PPI (pre or post)	54 (94.7)	81 (98.8)	35 (100)	0.079
Use of pre-PPI ^a	49 (86.0)	77 (93.9)	32 (91.4)	0.277
USe of post-PPI ^b	28 (49.1)	41 (50.0)	14 (40.0)	0.459

Values are presented as n (%).

^a Defined as using of PPI before endoscopic hemostasis

^b defined as using of PPI after endoscopic hemostasis.

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